Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance

NCT04934709 | Completed FDA Device

• 1 other identifier: 665332
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

There is evidence about the effects of photobiomodulation therapy (PBMT) alone and combined with static magnetic field (PBMT-sMF) on skeletal muscle fatigue, physical performance and post-exercise recovery in different types of exercise protocols and sports activity. However, it is unknown the effects of PBMT-sMF to improve the subsequent performance after a first set of exercise. Therefore, the aim of this study was to investigate the effects of PBMT-sMF, applied between two sets of exercises, on the subsequent physical performance.

Conditions

Skeletal Muscle Performance

Keywords

Photobiomodulation Therapy; Static Magnetic Field; Subsequent performance

Outcome Measures

Primary Outcomes (1)

• Fatigue index

  Variable provided directly by the isokinetic dynamometer during the exercise protocol.

  1 minute after the end of exercise protocol.

Secondary Outcomes (3)

• Total work

  1 minute after the end of exercise protocol.

• Peak torque

  1 minute after the end of exercise protocol.

• Blood lactate

  3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol.

Study Arms (2)

PBMT-sMF

EXPERIMENTAL

Volunteers underwent intervention (active PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol.

Device: Active PBMT-sMF

Placebo

PLACEBO COMPARATOR

Volunteers underwent intervention (placebo PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol.

Device: Placebo PBMT-sMF

Interventions

Active PBMT-sMF DEVICE

PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter. Six different sites of the knee extensor muscles (two medial, two lateral and two central points) were irradiated at the same time.

PBMT-sMF

Placebo PBMT-sMF DEVICE

Placebo PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter, but without any emission of therapeutic dose. Placebo PBMT-sMF was applied at six different sites of the knee extensor muscles (two medial, two lateral and two central points).

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male healthy volunteers;
• Non-athletes or those who practiced physical activity up to once a week;
• Aged 18-35 years.

You may not qualify if:

• History of musculoskeletal injuries in the hip and knee regions in the two months prior to the study;
• Use of pharmacological agents and nutritional supplements;
• Chronic joint disease in the non-dominant lower limb.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher programmed the device (placebo or PMBT-sMF) and was instructed not to inform the volunteers or other researchers as to the type of treatment (placebo or PBMT-sMF). Therefore, the researcher responsible for the treatment was blinded to the type of treatment administered to the volunteers. The sounds and signals emitted from the device as well as the information displayed on the screen was identical, regardless of the type of treatment (placebo or PBMT).
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 22, 2021
• Study Start: May 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BR (1)